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Here's Why Karyopharm Therapeutics Is Getting Hammered Today

By Cory Renauer – Updated Apr 20, 2019 at 5:24PM

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It looks like an upcoming FDA advisory committee meeting will be an uncomfortable affair for this clinical-stage biotech.

What happened

Shares of Karyopharm Therapeutics (KPTI 0.61%), a precommercial biopharmaceutical company, are plummeting in response to briefing documents released by the Food and Drug Administration ahead of an advisory committee meeting. Investors expecting a rough road ahead have knocked the stock 46.7% lower as of 3:56 p.m. EST on Friday.

So what

Karyopharm Therapeutics convinced the FDA to grant a priority review for selinexor, but the agency insisted on an advisory committee meeting to discuss the application with independent experts in a public setting first. Shortly before each of these meetings the agency publishes a giant briefing document that, among other things, describes issues likely to impede an approval.

A group of people in suits looking down at a colleague sprawled prone on a sidewalk

Image source: Getty Images.

Investors threw Karyopharm stock out a window today because the issues highlighted by regulators are almost certain to result in a negative recommendation. The application for accelerated approval is based on results from the single-arm Storm trial, which combined selinexor with a high dose of standard chemo for patients with relapsed and refractory multiple myeloma.

During the 123-patient Storm study, 25.4% of patients showed a response to treatment with selinexor plus chemo, which isn't a whole lot better than you'd expect from this group when treated with the same dose of chemo on its own.

Now what

Although selinexor plus chemo elicited a response from extremely difficult-to-treat patients, one look at the safety data says this combo therapy isn't going anywhere without proof of a survival benefit first. The Storm study treated just 123 patients, but 10 died due to treatment-emergent adverse events.

High-dose chemotherapy is dangerous by itself, and combining it with selinexor doesn't appear to make it any safer. A whopping 93.5% of patients treated with the combination required hospitalization due to side effects.

Although selinexor probably isn't going to earn an accelerated approval to treat fourth-line multiple myeloma, Karyopharm probably won't need to tap investors for more cash until its lead candidate has another chance to prove itself. The company finished December with $330 million in cash, which should be enough to keep operations humming along until early 2020.

Check out the latest Karyopharm earnings call transcript.

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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